DOI: 10.2337/dc06-0255 © 2006 by the American Diabetes Association
Assessment of Patients and Physicians Compliance to an ACE Inhibitor Treatment Based on Urinary N-Acetyl Ser-Asp-Lys-Pro Determination in the Noninsulin-Dependent Diabetes, Hypertension, Microalbuminuria, Proteinuria, Cardiovascular Events, and Ramipril (DIABHYCAR) Study
1 Institut National de la Santé et de la Recherche Médicale, CIC 9201, Paris, France Address correspondence and reprint requests to Michel Azizi, MD, PhD, Centre dInvestigations Cliniques, Hôpital Européen Georges Pompidou, 20-40 rue Leblanc, 75908 Paris cedex 15, France. E-mail: michel.azizi{at}egp.aphp.fr OBJECTIVEThe purpose of this study was to assess patients and physicians compliance with ACE inhibitor treatment, by measuring an endogenous biomarker of ACE inhibition, urinary N-acetyl-Ser-Asp-Lys-Pro (AcSDKP), in the Noninsulin-Dependent Diabetes, Hypertension, Microalbuminuria, Proteinuria, Cardiovascular Events, and Ramipril (DIABHYCAR) trial, which compared ramipril (1.25 mg o.d.) with placebo in 4,912 patients with type 2 diabetes and microalbuminuria/proteinuria. RESEARCH DESIGN AND METHODSThe urine AcSDKP-to-creatinine ratio was measured blind to treatment in all participants who completed follow-up and provided spot urine samples (n = 1,871).
RESULTSThe median urinary AcSDKP-to-creatinine ratio was six times higher for ramipril than for placebo. Urinary AcSDKP-to-creatinine ratios displayed a bimodal distribution in both groups, with a very large intergroup overlap. Based on cluster analysis, we defined truly adherent ramipril patients as those with a ratio CONCLUSIONSThe systematic use of spot urinary AcSDKP determination facilitated the detection of defects in compliance with ACE inhibitor treatment in both patients and physicians. Urinary AcSDKP measurement could be a useful biomarker for assessing compliance with ACE inhibition in the routine care of diabetic patients.
Abbreviations: AcSDKP, N-acetyl-Ser-Asp-Lys-Pro DIABHYCAR, Noninsulin-Dependent Diabetes, Hypertension, Microalbuminuria, Proteinuria, Cardiovascular Events, and Ramipril MICROHOPE, Microalbuminuria Cardiovascular Renal Outcomes-Heart Outcomes Prevention Evaluation SBP, systolic blood pressure UAE: urinary albumin excretion
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